Regulatory Affairs Consulting for all FDA regulated industries

Solutions cost less than problems! And we have the solution for you!

BGF Consultants are trained to support your regulatory needs from beginning to end!
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REGULATORY AFFAIRS SOLUTIONS

  • DEVELOPMENT OF REGULATORY STRATEGY
  • PREPARATION AND REVIEW OF REGULATORY FILINGS
  • REGULATORY INTERACTION SUPPORT
  • MANUFACTURING PROCESS EVALUATION AND OPTIMIZATION

Regulatory Training Solutions

  • GOOD MANUFACTURING PRACTICES (GMP) TRAINING
  • INSPECTION READINESS
  • CORRECTIVE AND PREVENTATIVE ACTION (CAPA)
  • PRESCRIPTION DRUG MARKETING ACT (PDMA) & SAMPLING HANDLING

AUDITING SOLUTIONS

  • SUPPLIER AUDITING
  • SERVICE PROVIDER AUDITING
  • INTERNAL AUDITING
  • COMPLIANCE GAP ANALYSIS AND REMEDIATION PLANS

Validation Services

  • VALIDATION MASTER PLAN
  • EQUIPMENT VALIDATION
  • PROCESS VALIDATION
  • FACILITY AND UTILITY Validation

Solutions Cost Less Money Than Problems

BGF is a group of consultants with direct industry experience, who provide regulatory compliance and project management expertise, to assist organizations in driving projects to completion, and preventing and remediating compliance challenges. We help organizations understand current regulatory expectations and provides common sense, stream lined solutions that can be efficiently sustained.

Our consultants provide hands-on assistance, project management and regulatory strategies to drive projects to an efficient and compliant close.  The bandwith of the multi-disciplinary team enables us to provide expertise in validation, regulatory compliance and approvals, quality systems and GMPs, analytical and microbiological analysis, and process development and improvement.

We operate domestically and internationally with companies operating within regulated environments, such as pharmaceutical, medical device, biotechnology, food, and nutritional companies.